AGEN · Agenus Inc

A Landmark Registrational Study Aiming to Redefine Outcomes in MSS mCRC Which Represents Approximately 95% of Metastatic Colorectal Cancer Cases Colorectal Cancer Has Become the Leading Cause of Cancer-related Death in Adults Under Age 50 Agenus Inc. (Nasdaq: AGEN) , a leader in immuno-oncology innovation, today announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy. This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic

Webcast on Tuesday, March 31, 2026, at 4:30 p.m. ET Agenus Inc. (“Agenus”) (Nasdaq: AGEN ), a leader in immuno-oncology, today announced it will host its March Stakeholder Webcast focused on continued progress of its botensilimab and balstilimab (BOT+BAL) immunotherapy program and will provide an update on the Company’s patient access programs, development across tumor types, and key priorities for 2026. The session will be moderated by Garo H. Armen, PhD, Founder, Chairman, and Chief Executive Officer of Agenus, and will conclude with a live Q&A. Featured Topics and Speakers Strategic Direction: Advancing BOT+BAL Garo Armen, PhD Founder, Chairman, and Chief Executive Officer, Agenus Dr. Armen will open the session by discussing Agenus’ mission to harness the immune system across tumor types and the urgency of advancing new options for patients with historically treatment-resistant cancers. He will also outline key priorities for 2026 as momentum continues to build across the

A novel, chemo-sparing strategy (BBoPCO): introducing BOT+BAL in 1L MSS mCRC to extend survival and reduce use of cytotoxic chemotherapy Agenus Inc. ( Nasdaq: AGEN ), a leader in immuno-oncology, today announced that preliminary results from an investigator-sponsored study evaluating botensilimab (BOT) in combination with balstilimab (BAL) in first-line microsatellite stable colorectal cancer (MSS CRC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 18–23 in San Diego, CA. The BBoPCO study (Botensilimab and Balstilimab Optimization in Colorectal Cancer; NCT06268015) is the first trial of its kind to advance a combination immunotherapy approach in the first-line setting for MSS mCRC, evaluating BOT+BAL in patients without liver, bone, or brain metastases—a population historically resistant to immunotherapy. This investigator-sponsored study was expanded to a Phase 2 and reflects a growing shift toward introducing

Early access programs expand globally: 200+ physician inquiries across 30+ countries; $4.2M in initial program revenue recognized CRC leads BOT+BAL clinical development: 42% two-year overall survival and ~21-month median overall survival in heavily pretreated microsatellite stable (MSS) metastatic CRC (mCRC) patients BATTMAN Phase 3 registrational trial underway: First global next-generation CTLA-4/PD-1 combination registrational trial in refractory MSS mCRC France expands reimbursed AAC access: Metastatic ovarian cancer and sarcoma added alongside MSS mCRC Zydus collaboration strengthens balance sheet and manufacturing capacity: Strategic capital and dedicated U.S. biologics production secured to support BOT+BAL development for commercialization Agenus Inc . (Nasdaq: AGEN) today reported financial results for the fourth quarter and full year ended December 31, 2025, highlighting progress for the botensilimab (BOT) plus balstilimab (BAL) immunotherapy program across patient access,

Work orders for key CMC and production activities activate first contingent payment as global demand expands across clinical and paid compassionate access programs Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has triggered the first $20 million contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls (CMC) and production activities related to botensilimab (BOT) and balstilimab (BAL). These activities will allow Zydus to perform the initiation of its commercial supply of Agenus’ lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization.

Agenus Inc. (“Agenus”) (Nasdaq: AGEN ), a leader in immuno-oncology, today announced that the Company will release its fourth quarter and year-end 2025 financial results before the market opens on Monday, March 16, 2026. Agenus will host a stakeholder briefing webcast in late March to spotlight key strategic plans, data milestones and provide an update on the global botensilimab (BOT) and balstilimab (BAL) development program. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations

Integrated analysis of systemic inflammation and tumor immune features identifies biologically distinct patient subgroups with differential survival outcomes, outperforming conventional biomarkers Agenus Inc . ( Nasdaq: AGEN ), a leader in immuno-oncology, today announced new translational and clinical biomarker data from its Phase 1b C-800-01 trial (NCT03860272) evaluating botensilimab (BOT), an Fc-enhanced anti–CTLA-4 antibody, in combination with balstilimab (BAL), an anti–PD-1 antibody. The data were presented today at the American Association for Cancer Research Immuno-Oncology (AACR-IO) Conference in Los Angeles. The retrospective analyses demonstrate that survival with BOT+BAL is associated with the balance of two opposing biological factors: systemic inflammation in the blood (associated with poorer outcomes) and tumor immune activity within the tumor microenvironment (TME) (associated with more favorable outcomes). Notably, BOT+BAL enabled clinical benefit even at levels of

Agenus Inc . ( Nasdaq: AGEN ), a leader in immuno-oncology, today announced that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program have been accepted for poster presentation at the American Association for Cancer Research- Immuno-Oncology (AACR-IO) Conference, taking place in Los Angeles, CA on February 18–21, 2026. The abstract, titled “Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab,” evaluates how systemic inflammatory markers, tumor microenvironment (TME) immune activity, and peripheral immune cell states are associated with clinical outcomes in patients treated with BOT alone or in combination with balstilimab (BAL). Botensilimab is an Fc-enhanced multifunctional anti-CTLA-4 antibody designed to help prime and activate the immune system, while BAL is an anti-PD-1 antibody designed to help sustain

Medical Affairs scale-up supports France’s multi-tumor AAC access framework and expanding paid named-patient programs requests Agenus Inc. (Nasdaq: AGEN) , a leader in immuno-oncology innovation, today announced the expansion of its global Medical Affairs infrastructure and early-access support capabilities in response to increasing physician-initiated interest regarding authorized access to the investigational immunotherapy combination botensilimab plus balstilimab (BOT+BAL). The expansion reflects increasing interest from treating oncologists worldwide seeking access to BOT+BAL for patients with advanced solid tumors through regulatory-authorized early access pathways, including France’s Authorisation d’Accès Compassionnel (AAC) framework and paid named patient programs (NPPs) where permitted. This interest follows a series of recent scientific milestones, including peer-reviewed publications, clinical data presentations at major international scientific meetings and the recent